The EMA Committee for Medicinal Products for Human Use have issued a number of guidelines relevant to biosimilars that
detail the requirements for market approval. The EMA guidelines cover a range of issues including manufacturing, measurement
and comparability, chemical and biological analysis, and clinical trial requirements. In addition to the pharmaceutical, chemical,
and biological data normally required for a generic-drug application, application for market approval of biosimilar products
require additional toxicological and other nonclinical and clinical data.
The key is to demonstrate that the biosimilar product is similar to the reference product in terms of quality, safety, and
efficacy. Products are dealt with on a case-by-case basis. The 2009 Biologics Price Competition and Innovation Act directed
the US FDA to develop a regulatory framework in support of developing biosimilars and also defined the pathway to achieve
drug approval. This pathway is based on a risk-based approach using what the agency has termed "totality of evidence." Working
with a partner who has experience with the regulators for both innovator and biosimilar products will help to build this body
Alison Armstrong is director of development services at BioReliance Ltd., Todd Campus, West of Scotland Science Park, Glasgow G20 0XA.
1. EMA, "Multidisciplinary: Biosimilar,"
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp, accessed July 22, 2013.
2. ICH, Q2(R1) Validation of Analytical Procedures, Step 4 version (1994).
3. S. Deechongkit et al., J Pharm. Sci. 95 (9) 1931–1943 (2006).
4. FDA, Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, MD, Feb. 2012).